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Xarelto

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Doctors prescribe the blood thinner Xarelto to help prevent the risk of stroke, deep vein thrombosis and pulmonary embolism. The medication works by blocking the creation of thrombin.

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What is Xarelto?

Xarelto, also known as rivaroxaban, is an anticoagulant. It keeps blood from clotting by blocking the creation of thrombin in the clotting sequence. 1 Thrombin is a precursor of fibrin, the “web” that stabilizes clots. 2

Xarelto and other direct thrombin inhibitors are classified as Factor Xa inhibitors (explained more in the following paragraphs).

Comparing Xarelto to Other Blood Thinners

Until Xarelto (and its direct competitors) entered the marketplace, low molecular weight heparin was the “newest” anticoagulant in use. 3 Other versions of heparin, along with warfarin, were approved in the U.S. approximately 60 years ago. 456

Warfarin has a narrow therapeutic range, necessitating frequent blood monitoring and following a restrictive diet. 7 Xarelto and its competitors were hailed as being more convenient to dose orally—sans blood monitoring—and were approved with no dietary restrictions. 8 Additionally, Xarelto’s manufacturer touted other advantages. Any dose lower than 15 mg didn’t have to be taken with food, and it was the first anticoagulant in its class to offer once-daily dosing.1 (Pradaxa, the first Factor Xa inhibitor to market, requires twice-daily dosing. 9)

Xarelto’s FDA-Approved Uses

The FDA has approved Xarelto for treating or preventing several types of vascular problems: 101112

Reducing the risk of stroke in people with nonvalvular atrial fibrillation (NVAF)

Nov. 2012

Treating DVT or PE and reducing the risk of recurrence after initial treatment

How Does Xarelto Work?

The body forms clots via a cascade sequence. Like dominoes falling, one component activates the next. Signaling that activates the start of the cascade can come from an extrinsic source (like getting a cut) or an intrinsic source (like a rough spot developing inside a blood vessel wall due to “bad” fats accumulating). Each source activates a different clotting pathway; but, at a certain point, the two pathways merge to finish the job of creating a clot. Factor Xa is active at the junction where those two pathways become one.2 Xarelto directly inhibits Factor Xa (also called FXa). 13

Xarelto inhibits clotting, whether due to an “extrinsic” factor (a cut) or an “intrinsic” factor (a disease process). “Intrinsic” triggers contribute to strokes, a host of vascular problems and other diseases; so the potential clinical utility for preventing cardiovascular complications by using such an anticoagulant is significant.

According to a February 2016 article published in The New York Times, the U.S. Food and Drug Administration (FDA) is looking into the possibility that a defective blood-testing instrument may have distorted the results of a study, ROCKET AF, involving Xarelto, an anticlotting drug. Based on those possibly inaccurate results, the FDA approved Xarelto for use.

Compromised Clinical Testing

According to a February 2016 article published in The New York Times, the U.S. Food and Drug Administration (FDA) is looking into the possibility that a defective blood-testing instrument may have distorted the results of a study, ROCKET AF, involving Xarelto, an anticlotting drug. Based on those possibly inaccurate results, the FDA approved Xarelto for use. 14

Since Xarelto’s approval several years ago, doctors have prescribed this medication to millions of Americans. Now, Janssen, whose parent company is Johnson & Johnson, and Bayer, manufacturers of Xarelto, are facing lawsuits claiming the drug caused injury to patients. 15

Researchers that oversaw the ROCKET AF study recently conducted an analysis suggesting that the original tests done to measure blood clotting did not significantly compromise safety or efficacy results. Although the FDA is proceeding with its investigation, the agency has advised consumers to continue taking Xarelto according to the manufacturer’s instructions. 16

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